510(k) K051787

TRIAGE BNP TEST, MODEL 98000XR by Biosite Incorporated — Product Code NBC

K051787 is an FDA 510(k) premarket notification submitted by Biosite Incorporated for the device "TRIAGE BNP TEST, MODEL 98000XR". The FDA issued a decision of Substantially Equivalent on September 22, 2005. The device falls under product code NBC (Test, Natriuretic Peptide), a Class II device regulated under 21 CFR 862.1117. Biosite Incorporated has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2005
Date Received
July 1, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Natriuretic Peptide
Device Class
Class II
Regulation Number
862.1117
Review Panel
CH
Submission Type